Modern business drivers are continually pushing to reduce the time it takes to get a product or service to market, reduce the risk and cost associated with that, and to improve quality. In laboratories, delivering an analytical result that’s ‘right first time’ (RFT) is the answer. There is no reprocessing data or re-running injections and no out of specification (OOS) results or reporting/calculation errors. Getting RFT analysis automatically gives high quality of results and confidence in results, lower cost of analysis, improved lab efficiency, and faster release to market and return on investment (ROI).
Text of Getting It “Right First Time” Seminar Series – Part 1 Right First Time, Every Time
1 The world leader in serving science Darren Barrington-Light Product Specialist, Thermo Scientific Dionex Chromeleon Chromatography Data System (CDS) Software, Thermo Fisher Scientific March 18, 2014 Getting It Right First Time Seminar Series Part 1 Right First Time, Every Time Part #: 71039_E 03/14S
2 Agenda Introduction How to get it right the first time? How can your CDS help? Thermo Scientific Dionex Chromeleon Chromatography Data System (CDS) Software tools for RFT analysis Summary
3 Introduction Modern business drivers are continually pushing to reduce the time it takes to get a product or service to market, reduce the risk and cost associated with that, and to improve quality Not doing a task right the first time usually creates more work We had a fundamental belief that doing it right the first time was going to be easier than having to go back and fix it. And I cannot say strongly enough that the repercussions of that attitude are staggering (Steve Jobs) Improving quality doesnt always mean more work Quality is free, provided [the task] is done right the first time and my favorite Genius is the ability to evade work by doing something right the first time
4 Introduction In laboratories, delivering an analytical result thats right first time (RFT) is the answer No reprocessing data No re-running injections No out of specification (OOS) results No reporting or calculation errors Getting RFT analysis automatically gives: High quality of results High confidence in results Lower cost of analysis Improved lab efficiency Faster release to market Faster return on investment (ROI)
5 How to Get It Right The First Time?
6 How to Get It Right The First Time? Reasons things dont go right the first time: Human operators are one of the biggest sources of errors in any complex system An experienced analyst who is 100% focused can still make 5 errors in 1000 simple data entries (0.5%) But what if they are inexperienced, arent 100% focused, or doing a complex task? Can rise 10 fold (5%) Other factors: Lack of preparation Rushing the task Lack of attention Leaving things undone
7 How to Get It Right The First Time? What do you need for RFT analysis in a laboratory? Robust and reliable instrumentation Robust, reproducible, and reliable methodology Highly trained, experienced operators? Preparation Documentation Qualification Training Reproducibility Removing the human error factor automation
8 How to Get It Right The First Time? Instrumentation Qualification Servicing and wear part monitoring maximize uptime. Methodology Standard operating procedures Document describing all steps and activities of a procedure that can be followed to guarantee a specific outcome i.e. ensure an analysis is always done the same way, no matter who performs it Streamlining Routine Chromatography Analyses Using eWorkflows webinar Validated analysis methods Demonstrate that an analytical procedure is suitable for its intended purpose i.e. it gives accurate results, reliably and under different circumstances Operators Training How to get inexperienced users as good as experienced?
9 How Can Your CDS Help? Guy scratching head looking at PC?
10 How Can Your CDS Help? Robust and reliable instrumentation Qualification automation Monitor instrument status Robust, reproducible, and reliable methodology Standard operating procedures Method validation Automated sequence creation Run-time checks In-run reactions to actual chromatographic results Automated result calculation and export Operators Make learning curve as shallow as possible Provide tools to help inexperienced users with more complex tasks
11 Chromeleon CDS Tools for RFT Analysis
12 Chromeleon CDS Tools for RFT Analysis Instrumentation Predictive performance instrument qualification, service and wear part monitors Methodology ICH Method Validation Templates eWorkflows Sequence Ready Check Smart Startup System Suitability Tests with Intelligent Run Control Spreadsheet-based Report Designer with integral Report Check Operators All the above combine to ensure ANY operator can achieve RFT analysis
13 Instrumentation Predictive Performance
14 Instrumentation Predictive Performance Combined with Thermo Scientific Dionex UltiMate 3000 LC, or some of the Thermo Scientific Dionex ICS Systems, Chromeleon CDS software provides several counters to monitor system performance: Some counters are expressed as dates (Service) Some counters are expressed as numbers (Wellness) For these counters it is possible to set: An Interval and a Warning Period (Service) A Limit and a Warning Limit (Wellness) Limits checked before running samples and appropriate warning messages provided to user The counter information is stored in module, not in software
15 Instrumentation Predictive Performance Predictive performance for Service and Wellness features are accessible through module ePanels
16 Instrumentation Predictive Performance Service Last service date, service interval and warning period are entered When reaching warning period, warning is written in audit trail and color changes to yellow When exceeding service interval, warning is written in audit trail and color changes to orange
17 Instrumentation Predictive Performance Wellness Wellness parameters work similar to service parameters For the wellness parameters it is possible to set limits and warning limits All limits are predefined by module designers, and default values regularly updated based on field input
18 Instrumentation - Predictive Performance - Qualification Keeps track of the qualification status of module For each module administrators can define Qualification interval Warning period Grace period Administrators can ensure users cannot work with modules after dates are exceeded The counters are stored in the modules
19 Benefits of Predictive Performance Instrument notifies you of impending service/qualification Allows you to schedule workload more effectively Improves instrument utilization Instrument notifies you of potential wear part failure Allows you to schedule instrument maintenance at most convenient time Improves instrument uptime Prevents you from working with out of qualification system Enforces regulatory compliance Information is stored in instrument firmware Ensures data is recorded and maintained at all times, even if module is moved/exchanged
20 Methodology Validated Methods
21 Methodology Validated Methods The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose, i.e. it gives accurate results, reliably and under different conditions Different analysts, instruments, columns, or consumables Variations in flow, inject volume, mobile phase composition It also tests scope of the method Concentration range Most pharma laboratories and pharmacopeias have standardized on ICH approach INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
22 ICH specifies 8 different tests and when to perform: Specificity Accuracy Precision Repeatability Intermediate Precision Reproducibility Detection Limit Quantitation Limit Linearity Range Robustness Methodology Validated Methods
23 Ensure robustness before you waste time validating! How long to validate an HPLC external standard assay method about 8 12 man days Creating the final report can take several hours Can be difficult to consolidate data Often need external spreadsheets Lots of opportunities for errors to occur Methodology Validated Methods
24 Chromeleon CDS Extension Pack ICH Templates Provide structured approach to method validation Not designed to create instrument methods or experimental design matrices (e.g. for robustness) Calculate all results and compare against specification Immediately notify you of failed tests Allow you to create your final validation report in a couple of minutes providing significant productivity gains Methodology Validated Methods
25 ICH Method Validation Templates Live Demo Lets have a look at how the Chromeleon CDS Extension Pack performs ICH Method Validation